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NCT06843382: ROOF-MS

Real-world Experience of Oral Agents On Fatigability in Multiple Sclerosis

Not yet recruiting Last updated 21 November 2025
What this trial tests

trial in Multiple Sclerosis in 100 participants. Not yet recruiting.

Timeline
20 November 2025
Primary endpoint
15 June 2027
15 June 2027

Quick facts

Lead sponsorTC Erciyes University
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment100
Start date20 November 2025
Primary completion15 June 2027
Estimated completion15 June 2027
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

TC Erciyes University

Who can join

Adults 18 to 75, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This multicenter, prospective, real-world study evaluates how two commonly used oral disease-modifying therapies-teriflunomide and dimethyl fumarate-affect physical and cognitive fatigability in adults with multiple sclerosis (MS). Fatigability refers to an objective decline in physical or cognitive performance during sustained activity and represents a major barrier to daily functioning for many individuals with MS. Participants starting either teriflunomide or dimethyl fumarate as part of routine clinical care will be followed for 12 months at regular visits (baseline, 3, 6, 9, and 12 months). At each visit, standardized assessments will measure walking endurance, gait performance, hand function, and information-processing speed. Patient-reported outcomes about fatigue, mood, quality of life, and daily functioning will also be collected. Brain MRI scans performed as part of usual care will be reviewed to document disease activity. The goal of the ROOF-MS study is to understand whether these two therapies differ in their impact on physical and cognitive fatigability, functional outcomes, symptom burden, and real-world treatment adherence. Because this is an observational study, no experimental treatments are given, and all clinical decisions remain the responsibility of the treating physicians. By examining fatigability in everyday clinical settings, this study aims to generate evidence that can help patients, families, and health care providers make more informed treatment decisions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

Other TC Erciyes University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06843382.

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